Conflict of Interest
Business Relationship Reporting
Business Relationship Reporting is now available on-line. Please follow this link to login: Business Relationship Reporting
In this new tool, each employee/investigator at the University will have a single disclosure to update and maintain. Business Relationship Reporting will combine the current conflict of interest disclosure process in ERICA for all research projects with the School of Medicine faculty disclosures of industry relationships in the Mission Based Management system.
The new tool will help you:
Business Relationship Reporting will require that you complete the Conflict of Interest Training Module before you begin. You must repeat this training module at least every four years. Additionally, each time you log into the tool, you will be directed to a page that provides key definitions used in the Disclosure Form. Understanding these definitions is essential to completing the Disclosure Form correctly. Please review these definitions carefully each time you log into the tool.
After completing the required training and acknowledging that you have read and understand the definitions, you will be directed to the "Manage Disclosures" section of the Disclosure Form. Here you will answer three initial questions to determine if you need to report any significant financial interests (or travel). Based on your responses to the initial questions, Business Relationship Reporting will guide you through making the appropriate disclosures.
After you have entered all information for your Disclosure Form, you will review the entries and certify that the information is complete and accurate in compliance with the University Conflict of Interest Policy. A history of your past certifications is available if you need to reference that information.
To view a short 5 minute video demonstrating how to use the tool, follow this link: Video Demonstration of Business Relationship Reporting
Summary of Major Changes to the
Individual Financial Conflict of Interest Policy (1-006)
A major revision of the Individual Conflict of Interest Policy was undertaken in 2009 and culminated with changes in federal financial regulations promulgated by the Department of Health and Human Service (DHHS) on August 25, 2011. The revised University policy takes effect August 24, 2012.
The changes to the policy are in compliance with all NIH, NSF, and FDA requirements. In general, the revised policy, rules and procedures apply the same requirements for the whole University community regardless of the source of funding. In certain circumstances, highlighted in italics below, we are only applying the DHHS standards to research funded by the Public Health Service (PHS).
All individuals are required to complete on-line Conflict of Interest training prior to submitting a disclosure form and at least every four years if participating in research sponsored by the Public Health Service. The training will be built into the Business Relationship Reporting disclosure process.
The personal financial information that investigators and employees are required to disclose to the University has been modified.
Significant Financial Interests
The revised definition of a “significant financial interest” lowers the de minimis thresholds individuals must report to the University:
- For publicly traded business entities, any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the business entity as of the date of disclosure, when aggregated for the individual and the individual’s family member, exceeds $5,000.
- For non-publicly traded business entities, any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated for the individual and the individual’s family member, exceeds $5,000, or any equity interest.
- Intellectual property rights and interests (e.g., patents, copyrights), when the patent application is filed or when the copyright is asserted or upon receipt of income related to such rights and interests, including royalty income from intellectual property owned by the University of Utah Research Foundation.
The revised policy requires disclosure of royalties received from the University for University owned IP.
The exemption for SBIR/STTR Phase I projects is eliminated.
Disclosure of a wider array of financial interests to the University
Investigators and employees are required to provide information about all significant financial interests that reasonably appear related to the their professional responsibilities to the Univesity, as defined by their department or job description. The University, rather than the investigator or employee, assumes responsibility for determining if a significant financial interest is relevant to a particular project or activity.
Disclosures need to be updated regularly
The policy retains the current trigger mechanisms for soliciting disclosures from investigators and employees engaged in the following: research and scholarly activities, intellectual property commercialization and procurement. Investigators and employees are required to update their disclosures at least annually and within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest that is related to their professional responsibilities to the University.
(applies only to investigators participating in research sponsored by or applying for funding from the Public Health Service)
The occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to the discloser’s institutional responsibilities must be disclosed unless the travel is reimbursed or sponsored by the following: federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. All travel expenses reimbursed through the University are exempt from disclosure.
Confidentiality and Public Accessibility about Conflicts of Interest
The revised policy clarifies that the University will comply with federal and state laws that may require public disclosure of information relating to identified conflicts of interest. This includes making certain information available to the public about the conflicts of interest of senior/key personnel participating in PHS funded research. This information will be made available on a publicly available web site. Additionally, the University may require public disclosure on the web site as part of a conflict management plan when appropriate under other circumstances, such as conflicts of interest involving human subjects research.
Stricter Standard for Human Subjects Research
The revised policy incorporates the “rebuttable presumption” for human subjects research, as recommended by the AAMC-AAU.* This stricter standard requires the Individual Conflict of Interest Committee to apply a presumption against the conduct of research with human subjects in any circumstance where the individual has a conflict of interest relating to the research. The Committee may approve conduct of the research by the individual only upon a finding of compelling circumstances and only when the Committee can craft an effective management plan to mitigate the conflict. Otherwise, the conflict must be eliminated or the conflicted individual may not be involved in the research project.
*AAMC-AAU (Association of American Medical Colleges-Association of American Universities). Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research. Washington, DC: AAMC; 2008.Report of the AAMC-AAU Advisory Committee on Financial Conflicts of Interest in Human Subjects Research
Strengthened Compliance Monitoring
(required for most conflicts including all conflicts identified for research projects sponsored by the Public Health Service)
When the Individual Conflict of Interest Committee determines that a conflict of interest exists and requires a management plan, the plan will in most cases require investigators and employees to submit reports on a regular interval (usually annually) to certify their compliance with the approved management plan.
Non-compliance: retrospective reviews and mitigation reports
(applies only to investigators participating in research sponsored by the Public Health Service)
Whenever a conflict of interest is not identified or managed in a timely manner, the University must complete a “retrospective review” of the investigator’s activities and the PHS funded research project to determine whether any PHS funded research, or portion thereof, conducted during the time period of the noncompliance was biased in the design, conduct, or reporting of such research. If bias is found, the University must notify NIH promptly and submit a mitigation report to the NIH.
Strengthened Committee Authority
For non-compliance with the policy, the Individual Conflict of Interest Committee has the authority to:
- Freeze research funds, or otherwise suspend, a project or projects related to the policy violation;
- Remove the individual found to be in violation from a role as Principal Investigator or Investigator on a project or projects related to the policy violation;
- Prohibit submission of new applications to the Institutional Review Board and/or the Office of Sponsored Projects until resolution of the relevant COI issues or for a specified period of time;
- Other restrictions as may be deemed appropriate by the Committee.
Under the current policy, the decisions made by the Committee may be appealed to the cognizant vice president. As revised, decisions made by the Committee may be appealed to a panel that includes the Senior Vice President for Academic Affairs, the Senior Vice President for Health Sciences, and the Vice President for Research. The decisions of the panel are final.
